MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-650Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Esophagus (2399)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On september 21, 2021, olympus medical systems corp.(omsc) received the literature titled "risk factors for complications after endoscopic treatment in chinese patients with early esophageal cancer and precancerous lesions".The purpose of this literature was to analyze the risk factors for complications after endoscopic treatment of early esophageal cancer and precancerous lesions and provides evidence for developing preventive measures against these complications.In the literature, it was reported as follows; a retrospective chart review was performed to identify all patients with an early esophageal cancer or precancerous lesions treated endoscopically from january 2009 to december 2015 at the national cancer center/cancer hospital, chinese academy of medical sciences, and peking union medical college.A total of 459 (368 male and 91 female) patients were included in the study, with an average age of 61 (35¿81) years and an average follow-up of 44.7 (19.3¿94.0) months.The esd was performed using a dual knife (kd-650q) and an endoscope (gif-q260j or gif-1t240 ) with a transparent cap attachment (d-201-11804).And emr was performed using a snare (sd-7p-1) and an endoscope with a plastic cap (maj-1990).Preventive coagulation using electrosurgical hemostatic forceps (fd-411qr; olympus) with a soft coagulation current of 80 w (icc 350; erbe) was performed on the exposed vessels and active hemorrhage.The total rate of complication was 24.6% (113/459) among the 459 patients.15 patients (3.3%) had delayed bleeding (twice in 2 patients), and all patients were successfully stanched using electrosurgical hemostatic forceps under emergency endoscopy.Further, 16 patients (3.5%) had perforation, which was handled by endoscopic clipping immediately after the procedure and they all recovered by conservative management.Also, 82 patients (17.9%) had stenosis and were all alleviated by endoscopic dilatations several times.The intraoperative bleeding was successfully treated by endoscopic electrocoagulation in this study, with no bleeding requiring emergency surgical treatment.The perforation was found in time after the procedure in 16 patients which were closed using titanium clips.All patients with perforation were successfully healed conservatively through postoperative fasting, gastrointestinal decompression, and timely application of antibiotics to control infection.Based on the available information, delayed bleeding and stenosis were not reported in a direct relationship with the subject device.Omsc assumes that delay bleeding and stenosis were not related to the subject device.In addition, omsc assumes that delay bleeding and stenosis might not be caused or contributed to a death or serious injury due to endoscopic treatments were successful.However, 16 perforations might be related to the subject device due to using esd with the subject device.And, all patients with perforation were successfully healed conservatively through postoperative fasting, gastrointestinal decompression, and timely application of antibiotics to control infection.However, these treatments might be controlled in the hospital.Therefore, omsc assumes that the perforation might be caused or contributed to a death or serious injury due to hospital care.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Therefore, omsc will submit a medical device report (mdr) of the subject device for 16 perforations that might be controlled in the hospital.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12573881
• MDR Text Key: 275237251
• Report Number: 8010047-2021-12690
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: KD-650Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/04/2021
• Supplement Dates Manufacturer Received: 03/28/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization